Erik Vollebregt has just released a blog that should be read by anyone with a medical device or whose technology is likely to be classified as a medical device under the new Medical Devices Regulation (MDR – Regulation 2017/745/EU) which replaces the MDD in early 2020. It makes scary reading as to what will need doing to comply with the new regulations as approval under the MDD will no longer apply (no ‘grandfathering’). MedTech Europe has helpfully produced a flowchart describing the necessary steps. Advice from official sources given to this editor is that, as the MDR already applies in the EU, its continued application in the UK after Brexit is not in serious doubt, so UK companies should not delay.
The Digital Health & Care Alliance (disclosure; that this editor manages) and DigitalHealth.London are jointly running a digital health safety conference on 7th November. Key players in the UK are on the agenda (including the CQC, MHRA, HSIB, NHS Digital/England, Datix, Vitalpac etc.). This is a topic that requires the attention of all developers and providers of digital health, as new technology, being unfamiliar, is inherently risky. It is therefore really key for everyone involved to share experiences, understand the risks and carefully plan avoidance and mitigation. The draft agenda and booking details are here (there is a small charge for lunch).
For those who have doubts about the benefits that mobile communications can bring at times, a read of the GSMA’s 2017 report on mobile’s contribution to the UN’s sustainable development goals will fill you full of optimism of what technology can do, for health and many other aspects of life. Beautifully presented and full of interesting facts: recommended! (If you’ve not enough time, the summary is here.) Hat tip to Prof Mike Short.
Here is your opportunity as an SME to get advice on selling to the NHS. Specfically, DHACA and Kent Surrey & Sussex AHSN have joined forces to help you to prepare a more compelling and comprehensive value proposition as part of your market access strategy. (SMEs don’t need either to be in the KSS AHSN catchment areas, or members of DHACA, although the latter is free to join and has lots of useful digital health resources, so why wouldn’t you?)
There will be two sessions, both of which you should be able to attend if you apply. These will be held at the Royal Society of Medicine (close to Oxford St and Bond St tubes). That on 20th July will be about 90 minutes. In that time you will hear and be able to discuss:
- How current NHS finances and cash flow may impact on your service/product uptake
- How to improve your value proposition for NHS audiences
This will help you prepare for the second stage, on 27th July, which will be an individual Innovation Surgery. These will last 1 hour and cover aspects from the market access briefing. They will be specific to your product as well as covering the technical and market potential of your product/service.
More details and how to apply are available in the DHACA Briefing and Surgery Flyer
Note that although the flyer says you need to email firstname.lastname@example.org by the end of Thursday 6th July to apply, Vivienne will be happy to accept late applications, though do please get them in soon!
(Disclosure: this editor is Managing Director of DHACA)
Sadly the DHACA Day in Leeds on 27th April had to be cancelled because of competing events on that day – readers are reminded of the next DHACA Day now in London on 21st June – agenda still to be set.
Elsewhere, Nesta has updated its European Digital City Index, showing the position at the end of 2016
of the top 50 cities in Europe for start-ups. Not digital health-specific though very interesting, nevertheless. TechCity have produced a more detailed website exploring why the UK is the Tech Nation of Europe, which is excellently animated. Though with little mention of digital health it is nevertheless an excellent read, and resource…and something to make those of us who are involved in the UK digital scene proud of our achievements. And if you are a supplier looking for opportunities to capitalise on the UK’s standing, what better than to attend Healthcare UK and NHS Digital’s International Digital Health Opportunities event in London on 25th April?
If you are still feeling international though less interested in exporting, perhaps you might like to attend (more…)
Friday’s BBC Radio 4 TODAY breakfast show has two segments discussing the Care Quality Commission‘s public warning on online prescription services and potential danger to patients. The first is a short interview of Jane Mordue, Chair of Healthwatch England and independent member of the CQC (at 00:36:33-00:39:00). The second, longer segment at 02:37:00 going to 02:46:30 features our own Editor Charles Lowe, in his position as Managing Director of the Digital Health and Care Alliance (DHACA), debating with Sandra Gidley, Chair of the Royal Pharmaceutical Society (RPS) English Board. The position of the RPS is that a face-to-face appointment is far preferable to an online service, whereas Mr Lowe maintains that delays in seeing one’s GP creates a need for services where a patient can see a doctor online and receive a prescription if necessary. The quick response allays anxiety in the patient and provides care quickly. Both agreed that a tightening of guidelines is needed, especially in the incorrect prescribing of antibiotics, and that there is no communication between patient records. Mr Lowe notes that GPs have always been comfortable with a telephonic consultation but are far less so with telemedicine consults via Skype. Here’s the BBC Radio 4 link available till end of March.
In the US with 24/7/365 telemedicine services such as Teladoc, MDLive and American Well, there is a similar problem with patient records in many cases except for history that the patient gives, but this is an across the board problem as the US does not have a centralized system. The prescribing problem is less about antibiotics, though MRSA/MSSA resistant superbugs are a great concern. According to Jeff Nadler, CTO of Teladoc during his #RISE2017 presentation here in NY attended by this Editor, Teladoc has a 91 to 94 percent resolution rate on patient medical issues. Of that 9 percent unresolved, 4 percent are referred, 2 percent are ‘out of scope’, 1 percent go to ER/ED–and 2 percent of patients are ‘seeking meds only’, generally for painkillers. Teladoc’s model is B2B2C, which is that patients access the service through their health plan, health system, or employer.
28 April, 9:30am-5pm, Royal College of Obstetricians and Gynaecologists, London
Henry Purcell of the BJC was kind enough to post us with information on the first-ever BJC Digital Healthcare Forum. Organized by the BJC in association with the NHS, the Digital Health and Care Alliance (DHACA), and the Telehealth Quality Group, it is a novel ‘hands on’ meeting to assess if digital medicine can fill gaps in healthcare provision throughout the NHS. It is also in response to the massive pressures which winter has wrought on NHS health and social services. The Forum was designed by clinicians and leaders in healthcare informatics for UK commissioners, doctors and other HCPs involved in the management of long-term conditions (cardiovascular, obstructive pulmonary disease, diabetes etc.), as well as those engaged in health informatics, IT, and Trust CEOs. Speakers include Dr Malcolm Fisk of De Montfort University, our own Charles Lowe of DHACA, Professor Tony Young, National Clinical Director for Innovation (NHS England) and many more experts in digital health and care. For the latest information and to register, see the event website or the attached PDF.
It all started so simply. In DHACA under the leadership of Rob Turpin (BSI) we produced the definitive guide to app regulation in the UK. Sure it was 44 pages long (and will shortly need updating) however we all knew that an app was standalone software and that none other than MEDDEV 2.1/6, the ultimate definitive guide to when an app is a medical device defined software as:
…a set of instructions that processes input data and creates output data.
However doubts began to creep into this editor’s mind when he heard that app developers in the US were avoiding (US/FDA) medical device classification as that would rule them out as service providers, which can reduce future reimbursement benefits – as we quoted Ralph-Gordon Jahns of research2guidance in 2014 “profitable developers… rely on service sales as their primary source of revenue.”
Things got more complicated when it emerged at the UK Health Show this autumn that PHE was considering listing digital GP services as (more…)
The Accelerated Access Review is published today. Readers with long memories will recall that it kicked off in the Spring of 2015 aimed at accelerating the uptake of innovation in to the NHS. It had three technical streams – pharma, medtech & digital health, plus a patient stream. This editor, as Managing Director of DHACA, was the digital health champion.
DHACA members were heavily engaged in the consultation, so it is gratifying to see that all DHACA recommendations were accepted. Most important were recommendations that:
- NICE broaden its reach to include more medtech & digital health recommendations, and consider other means of funding;
- there be closer alignment of regulatory and NICE data requirements and processes (currently, there can be duplication);
- a strategic commercial unit is established in the NHS;
- a small amount of funding is offered to support the commercialisation of disruptive innovative technologies that significantly change care pathways;
- products not referred to NICE should be assessed only once by NHSE;
- the route for digital products should build on the “Paperless 2020” simplified app assessment process;
- the Crown Commercial Service, in partnership with NHS Digital, NHS England, the Department of Health and other system and technology partners, should consider how best to develop an accessible, simple and swift competitive process for procuring digital products from SMEs;
- NHS England, working with NHS Digital, should develop a generic framework for app prescription.
When implemented, these and all the other recommendations in the report will go a long way to (more…)
DHACA is holding its tenth DHACA Day on October 6th, three minutes’ walk from Leeds station. We have a wide array of fascinating speakers, with a keynote by Bethany Gildersleve, Head of Operations at NHS Digital. Membership of DHACA is free, though we have to make a small charge for lunch. For more details, and to book, go here.
The Royal Society of Medicine (RSM) is holding an event on Point-of-Care-Testing, a technology that enables radical improvement to care pathways that improve patient outcomes and can dramatically reduce costs. Keynote will be Prof Chris Price, Visiting Professor in Clinical Biochemistry, University of Oxford, widely recognised as the leading authority in the world on the topic. For more details, and to book, go here.
The RSM has an earlybird (ie even lower cost) offering for our mHealth app conference on April 4th 2017 – these rates will last until 29th November. For more details, and to book for this event, now in its fifth year & which has serially sold out, go here.
The RSM is also has another long-running and regularly very well-attended event on 28th February entitled Recent Developments in Digital Health. Last February’s presentation by Mustafa Suleyman, co-founder of Google DeepMind, is still being talked about. Details and booking here.
Finally the London Health Technology Forum has its first Autumn meeting on 20th October, covering the true story of how a start-up made its first sale to the NHS from both the point of view of the seller and from that of the NHS buyer. Attendance is completely free – book here. (While you’re at it, you may want to book for the Christmas Pitch too, as it’s certain to be fully booked before it takes place on 24th November.)
Disclosure: all the above have had some involvement, to a greater or lesser extent, from this editor.
Asthma UK has decided on a most exciting initiative to educate the tech industry on how they can best support the condition with new technology. Spearheading this activity will be this new role which is also expected to bring expertise to developing those digital health solutions: part stakeholder management, part UX designer.
If you want to know more, Joe Clift, Senior Policy Officer at Asthma UK, who is working alongside this new role, will be talking at the next DHACA Day in Leeds on October 6th (book here).
Details of the application are here. Applications close on 9th October.
This was the month when the UK Press seemingly finally woke up to the existence of STPs (Sustainability & Transformation Plans). This article by Derek du Preez and this in Digital Health are two one of a few that pick out the hope that digital health can help with making the NHS more sustainable. Sadly the headlines were grabbed with concern over closing hospital beds, which politicians in the UK still seem to consider to be a Bad Thing. Even though hospital beds have been reduced in most European countries over recent years, and those such as Denmark now trumpet reductions in hospital beds as progress, we have still to break the connection in people’s minds in the UK that beds are a good surrogate for health service delivery volume, (even though when pressed no individual seems keen to spend longer in hospital than absolutely necessary, or would prefer a treatment as an inpatient over treatment as an outpatient.)
Though not directly connected, the NHS offered over £100m to acute care trusts for “global digital excellence” – in line with the previous comments, perhaps the money could alternatively be spent on the UK building on its excellent primary care IT with the specific intention of moving more treatment out of hospitals…and follow that up with a proposal to put the hospital that is judged to be the least “globally digitally excellent” (more…)
Fancy a startup in Barcelona? Look no further than the NUMA Barcelona Accelerator. Note entries needed by 25th September.
The Biomedical Catalyst 2016 early stage award competition requires registrations by 7th September, applications in by 14th September.
The European Commission has opened a public consultation on the safety of apps and other non-embedded software as part of an effort to ensure a high level of health, safety and consumer protection. Be sure to respond by closing date of 14th September.
Baker Botts, the international firm of lawyers specialising in intellectual property has very kindly agreed to continue to support the London Health Technology Forum which has now agreed three evening events this autumn, on 15th September, 20th October & 24th November. The programmes are (more…)
Hazel Harper, Programme Manager, Health & Care, at Innovate UK has kindly offered readers this guest blog (which is also available on the Innovate UK website).
Delivering Assisted Living Lifestyles at Scale (dallas) is the largest innovation programme in Health and Care to date. With an ambitious target of touching the lives of over 160,000 people, just exactly what can we learn from this ambitious programme?
It was no mean feat. With no blueprint combined with delivering business as usual and only 3 years to deliver there are plenty of lessons but the question is how many of them will we really learn or will our incessant need to do things our way or no way remain the longest running barrier to progress we’ve known in this space?
Insight in to some of the lessons learnt (in no particular order)
This has proved to be a great week for digital health credibility.
Firstly Sleepio picked up two honours – one was scoring the highest mark on the first Ranked Health output. The second was getting the American College of Physicians to come out and say that CBT-I should be the treatment of choice for insomnia (above hypnotics).
Meanwhile a study has shown that “A Smart Phone-based ECG Recorder Is Non-inferior to an Ambulatory Event Monitor for Diagnosis of Palpitations”. In layman’s language, the Alivecor/Kardia smartphone peripheral and app are as good as the awkward to wear & cumbersome Holter monitor.
Well done both!
Those who have heard Dr Sophie Bostok, the indefatigable Sleepio Sleep Evangelist, explain (more…)
As some readers will be aware, this editor is involved in organising a range of low-cost, and free, digital health events. Two that should be of interest to all commercially-minded readers are:
On Friday 22nd April DHACA is holding its eighth members’ day at the Conference Centre at 1 Victoria St., this time focusing on customer mapping: how do you identify and contact the right person in the NHS to sell your digital health product or service to? We will have Siobhan Jones, a Deputy Directory in the Department of Health, John Currie a senior procurement manager in NHS England, and Karen Livingstone, National Director of SBRI Healthcare, NHS England, and Director of Partnerships & Industry, Eastern AHSN to help us. However the most important part of the day will be attendees sharing what works & what doesn’t. Membership of DHACA is free (though we do need to make a small charge for refreshments). Do come along – book here.
Then on the evening of the 28th April the London Health Technology Forum is holding an event kindly sponsored by Baker Botts on the assessment & regulation of medical apps. Confirmed for the evening is Julian Hitchcock, a partner in Denoon Legal, who gave a masterful presentation recently at the RSM medical apps event – this is particularly important considering the EU GDPR finalisation and changes expected as the Medical Devices & In Vitro Devices Directives are converted to regulations. Book here – attendance is completely free.
research2guidance has shared with the Editors some of the preliminary results of the 6th Global mHealth App Developer Economics Study. Currently at 2,000 participants and open till the end of May (click here to take the 15 minute survey), it has grown to be the largest global market study of the sector. (Last year’s study topped out at more than 5,000 industry respondents and is available as a free download here.) For their time, respondents can view initial results upon completion of the survey, after publication in 2nd Quarter receive a copy of the report and be automatically entered into their prize draw of an Apple Watch or Samsung Gear.
Many of the results to date are neatly summarized in the infographic at left and below:
- 61 percent believe mHealth solutions can cut costs through therapy adherence
- 65 percent believe mHealth adoption could save costs by shortening or avoiding hospital visits
- Market potential as a distributor: app stores still lead (61 percent) but half believe health insurers are now second. Doctors and hospitals trail at 42 percent and 38 percent respectively.
- Most positive impact: following up and monitoring of conditions; information provision; diagnosis and treatment
- But goals are still distant: 53 percent of respondents revealed they had only “partly achieved their goals”. 4 percent claimed their mHealth “dreams came true”. (Perhaps those who had their companies acquired? — Ed.)
TTA and DHACA (Editor Charles, Managing Director) are media partners for this study. Hat tip to Sean Phillips of r2g. Previously in TTA, Charles’ original article.
The Health KTN and UK Health Data Analytics Network (UK-HDAN) invite practitioners and industry experts to attend one of their regional workshops to contribute to a UK health data analytics roadmap for funders and policy-makers.
There is general recognition that health data analytics will play a critical role in transforming health and social care, but relatively poor understanding of the current UK landscape, research priorities and barriers to translation. Their aim is to provide a clear statement of opportunities and challenges that will help shape a national action plan for health data analytics.
The UK-HDAN is a newly formed community of health data scientists (current membership 350) working together to map the landscape and inform a national strategy for health data analytics research. They are particularly keen to (more…)